(79 days)
Not Found
No
The document describes a laser system for aesthetic and surgical applications and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
The device is intended for use in surgical and aesthetic applications and is indicated for various treatments for dermatological and vascular lesions, wrinkles, hair reduction, and other conditions, which are therapeutic in nature.
No
The device is used for surgical and aesthetic applications, such as hair reduction, treatment of lesions, wrinkles, and coagulation, which are therapeutic or cosmetic procedures, not diagnostic ones.
No
The device description explicitly states it comprises a variety of laser and non-laser light sources, a system console, permanently attached laser handpiece, footswitch, handpiece resting tree, and detachable pulsed light handpieces. These are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery." It describes treatments performed directly on the patient's body (hair reduction, lesion treatment, wrinkle treatment, surgical applications).
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not analyze specimens.
- Device Description: The device description details a laser system designed to deliver light energy to the body, not to process or analyze biological samples.
The information provided consistently points to a therapeutic and aesthetic device used externally on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cutera Family of CoolGlide Aesthetic Lasers is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
755 nm:
The Family of CoolGlide Aesthetic Lasers is indicated for temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The Family of CoolGlide Aesthetic Lasers is also indicated for:
- · treatment of benign pigmented lesions
• treatment of wrinkles
· photocoagulation of dermatological vascular lesions, such as, but not limited to, port wine stains, hemangiomas and telangiectasias
1064 nm:
Dermatology:
The Family of CoolGlide Aesthetic Lasers is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scriae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lessons, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The CoolGlide lasers are also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The CoolGlide lasers are indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The CoolGlide lasers are also indicated for the treatment for pseudofolliculitis barbae (PFB).
The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The lasers are also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The intended use of the integral cooling system in the CoolGlide laser handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments.
Surgical Applications:
The lasers are indicated for the incision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neckl otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia), and urology.
532 nm:
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening. blanching, flattening, reduction of lesion size).
Optional Pulsed Light Handpiece:
For the treatment of benign pigmented lesions.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Cutera Family of CoolGlide Aesthetic Lasers comprises a variety of laser and non-laser light sources, including single wavelength (755 nm Alexandrite, 1064 nm Nd:YAG or 532 nm Nd:YAG), multiple wavelength, pulsed light, and laser/pulsed light combination models. The Family of CoolGlide Aesthetic Lasers treats a wide range of dermatologic conditions requiring selective photothermolysis of target chromophores.
The Family of CoolGlide Aesthetic Lasers consists of a system console, permanently attached laser handpiece, footswitch, handpiece resting tree, and detachable pulsed light handpieces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety
IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance
Software Verification and Validation Testing Report V0066 rC Excel HR- Production V&V 2.1.0
Clinical Study: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K132185, K023954, K120235, K143723
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2016
Cutera, Inc. Ms. Julia Brown Manager, Regulatory Affairs 3240 Bayshore Blvd. Brisbane, California 94005
Re: K153671
Trade/Device Name: Family Of Coolglide Aesthetic Lasers Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: December 18, 2015 Received: December 21, 2015
Dear Ms. Julia Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153671
Device Name Family of CoolGlide Aesthetic Lasers
Indications for Use (Describe)
The Cutera Family of CoolGlide Aesthetic Lasers is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
755 nm:
The Family of CoolGlide Aesthetic Lasers is indicated for temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The Family of CoolGlide Aesthetic Lasers is also indicated for:
- · treatment of benign pigmented lesions
• treatment of wrinkles
· photocoagulation of dermatological vascular lesions, such as, but not limited to, port wine stains, hemangiomas and telangiectasias
1064 nm:
Dermatology:
The Family of CoolGlide Aesthetic Lasers is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scriae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lessons, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The CoolGlide lasers are also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The CoolGlide lasers are indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The CoolGlide lasers are also indicated for the treatment for pseudofolliculitis barbae (PFB).
The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The lasers are also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The intended use of the integral cooling system in the CoolGlide laser handpiece is to provide cooling of the skin prior to
3
laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments.
Surgical Applications:
The lasers are indicated for the incision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neckl otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia), and urology.
532 nm:
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening. blanching, flattening, reduction of lesion size).
Optional Pulsed Light Handpiece:
For the treatment of benign pigmented lesions.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
This 510(k) Summary of Safety and Effectiveness for the Family of CoolGlide Aesthetic Lasers is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(k) Summary.
| Applicant: | Cutera, Inc. |
|---|---|
| Address: | 3240 Bayshore Blvd. |
| Brisbane, CA 94005 | |
| Contact Person: | Julia Brown |
| Telephone: | |
| Fax: | |
| Email: | 415-657-5575 – phone |
| 415-715-3575 – fax | |
| jbrown@cutera.com | |
| Preparation Date: | December 18, 2015 |
| Device Trade Name: | Family of CoolGlide Aesthetic Lasers |
| Device Common Name: | Dermatology Laser |
| Device Classification Name: | Instrument, Surgical, Powered, laser |
| 79-GEX, 21 CFR 878.4810 | |
| Legally Marketed Predicate | |
| Device: | Family of CoolGlide Aesthetic Lasers (K132185) |
| Family of Altus Medical CoolGlide Aesthetic Lasers with | |
| Optional Pulsed Light Handpiece (K023954) | |
| Aerolase Model Nd:YAG 1064 nm Laser (K120235) | |
| Fotona Dynamis Pro Family (K143723) | |
| Description of the Family of | |
| CoolGlide Aesthetic Lasers: | The Cutera Family of CoolGlide Aesthetic Lasers comprises |
| a variety of laser and non-laser light sources, including | |
| single wavelength (755 nm Alexandrite, 1064 nm Nd:YAG or | |
| 532 nm Nd:YAG), multiple wavelength, pulsed light, and | |
| laser/pulsed light combination models. The Family of | |
| CoolGlide Aesthetic Lasers treats a wide range of | |
| dermatologic conditions requiring selective photothermolysis | |
| of target chromophores. | |
| The Family of CoolGlide Aesthetic Lasers consists of a | |
| system console, permanently attached laser handpiece, | |
| footswitch, handpiece resting tree, and detachable pulsed | |
| light handpieces. |
5
Intended use of The Family of The Family of CoolGlide Aesthetic Lasers is intended for CoolGlide Aesthetic Lasers: use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
Specific Indications:
755 nm:
The Family of CoolGlide Aesthetic Lasers is indicated for temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The Family of CoolGlide Aesthetic Lasers is also indicated for:
- · treatment of benign pigmented lesions
- treatment of wrinkles
- · photocoagulation of dermatological vascular lesions. such as, but not limited to, port wine stains, hemangiomas and telangiectasias
1064 nm:
Dermatology:
The Family of CoolGlide Aesthetic Lasers is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The CoolGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The CoolGlide lasers are indicated for temporary and permanent hair reduction. Permanent hair reduction is
6
defined as long-term, stable reduction in hair counts observed at 6. 9. and 12 months after the end of a treatment regime.
The CoolGlide lasers are also indicated for the treatment for pseudofolliculitis barbae (PFB).
The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The lasers are also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The intended use of the integral cooling system in the CoolGlide laser handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments.
Surqical Applications:
The lasers are indicated for the incision/excision and cutting. ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia), and urology.
532 nm:
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas. hemangiomas (port wine), telangiectasias (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, caféau-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
Optional Pulsed Light Handpiece:
For the treatment of benign pigmented lesions.
7
| Performance Data: | IEC 60601-1 Medical Electrical Equipment - Part 1: General
Requirements for Safety |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| | IEC 60601-1-2 Medical Electrical Equipment 1-2 General
Requirements for basic safety and essential performance |
| | Software Verification and Validation Testing Report
V0066 rC Excel HR- Production V&V 2.1.0 |
| Results of Clinical Study: | None |
| Summary of Technological
Characteristics: | See below |
8
Table 5—Technical Specification Comparison
| | Family of CoolGlide
Aesthetic Lasers
(new submission) | Family of CoolGlide
Aesthetic Lasers
(K132185) | Family of Altus Medical
CoolGlide Aesthetic Lasers
with Optional Pulsed Light
Handpiece (K023954) | Aerolase Model Nd:YAG
1064nm Laser
(K120235) | Fotona Dynamis Pro Family
(K143723) |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------|
| Wavelength(s) | 755 nm Alexandrite laser
1064 nm Nd:YAG laser
532 nm Nd:YAG laser
500-1300 nm pulsed light | 755 nm Alexandrite laser
1064 nm Nd:YAG laser
532 nm Nd: YAG laser
500–1300 nm pulsed light | 1064 nm Nd:YAG laser
532 nm Nd:YAG laser
500-1300 nm pulsed light | 1064 nm Nd:YAG laser | 1064 nm Nd:YAG laser |
| Spot Size | 755 nm: 5–18 mm
1064 nm: 3–18 mm
532 nm: 2–12 mm
500–1300 nm: 30 x 10 mm | 755 nm: 5, 8, 10, 12, 15, and 18 mm
1064 nm: 3, 5, 8, 10, and 12 mm
532 nm: 2–12 mm
500-1300 nm: 30 x 10 mm | 1064 nm: 0.1-50 mm
532 nm: 0.1-50 mm
500–1300 nm: 30 x 10 mm | 1 mm (for podiatry); ≤13 mm
(for other indications) | 3, 6, and 9 mm |
| Output Mode | Pulsed | Pulsed | Pulsed | Pulsed | Pulsed |
| Repetition
Rate | 755 nm: ≤2 Hz and single shot
1064 nm: ≤10 Hz and single shot
532 nm: ≤4 Hz and single shot
500-1300 nm: ≤1 Hz and single
shot | 755 nm: ≤2 Hz and single shot
1064 nm: ≤10 Hz and single shot
532 nm: ≤4 Hz and single shot
500-1300 nm: ≤1 Hz and single
shot | 1064 nm: ≤100 Hz and single shot
532 nm: ≤100 Hz and single shot
500–1300 nm: ≤1 Hz and single
shot | 5-100 Hz | ≤100 Hz |
| Laser Media | Flashlamp-pumped solid
state rod | Flashlamp-pumped solid
state rod | Flashlamp-pumped solid
state rod | Flashlamp-pumped solid
state rod | Flashlamp-pumped solid
state rod |
| User Interface | Push button control or LCD color
touchscreen | Push button control or LCD color
touchscreen | Push button control or LCD color
touchscreen | LCD color touchscreen | LCD color touchscreen |
| Aiming Beam | 755 nm: 630-680 nm
1064 nm: 630-680 nm
532 nm: 630-680 nm
500-1300 nm: none | 755 nm: 630-680 nm
1064 nm: 630-680 nm
532 nm: 630-680 nm
500-1300 nm: none | 1064 nm: 630-680 nm
532 nm: 630-680 nm
500-1300 nm: none | 630-680 nm | 650 nm |
| Delivery
Devices (How
Supplied) | Non-sterile, reusable,
cleanable | Non-sterile, reusable,
cleanable | Non-sterile, reusable,
cleanable | Non-sterile, reusable,
cleanable | Non-sterile, reusable,
cleanable |
9
Conclusion: Based on a comparison of technical specifications, intended uses, and indications for use, the Family of CoolGlide Aesthetic Lasers has been shown to be substantially equivalent to the previously cleared Family of CoolGlide Aesthetic Lasers (K132185), Family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Handpiece (K023954); Aerolase Model Nd:YAG 1064 nm Laser (K120235); Fotona Dynamis Pro Family (K143723).